Doxofylline: Patients will receive a 4-week treatment with doxofylline 400 mg bid, in addition to their chronic usual inhalation therapy.
Study summary
It is a phase IV, prospective, interventional, single blind, randomized, crossover trial in which the investigators will evaluate the effects of a 4-week treatment with doxofylline 400 mg bid, in add-on to maximal inhalation therapy, in clinically stable COPD patients.
Eligibility
Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* COPD diagnosis for at least 6 months, according to current European Respiratory Society guidelines
* baseline FEV1 ≤ 80% of predicted value
* active or former smokers with smoking history ≥ 10 pack-years
* patients chronically treated with a long acting muscarinic antagonist (LAMA) and a long acting beta-2 agonists (LABA), in association with or without an inhaled corticosteroid (ICS)
* clinically stable disease for 6 months.
Exclusion Criteria:
* previous or current diagnosis of bronchial asthma
* previous lung volume reduction through surgery or endobronchial valves
* inability to perform respiratory function tests according to international standards, or contraindications to perform 6-minute walking test
* known allergy or intolerance to doxofylline
* current or potential pregnancy
* mini-Mental test \<21
* congestive heart failure NYHA III or IV
* recent (\<6 months) myocardial infarction
* unstable arrhythmias
* chronic hypotension
* active peptic ulcer
* severe liver disease
* active neoplasia
* history of drug or alcohol abuse.
Primary outcome measure(s)
Difference in changes in FEV1 after 4 weeks of treatment — 4-8 weeks Difference between changes in the Forced Expiratory Volume in one second (FEV1) measured at baseline and the FEV1 after 4 weeks of treatment with doxofylline in addition to inhalation therapy, measured 30 minutes before the morning dose of doxofylline plus inhalation therapy, and changes in the FEV1 measured at baseline and the FEV1 after 4 weeks of treatment with inhalation therapy only, measured 30 minutes before the morning dose of inhalation therapy.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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